Many of you may have seen the ads for a new drug recently approved by the FDA for women with Hypoactive Sexual Dysfunction. Dr. Carr has been an advocate of more research and product development for women for years, and it is this diligence in finding a solution to sexual dysfunction that led to the development of Lotus Cream. However, Dr. Carr will not prescribe Addyi, as in his opinion it has very limited if any efficacy, does not address the underlying problem for women, and has significant side effects and limitations, such as complete abstinence from alcohol. The cause for many women who develop sexual dysfunction with age has to do with decreased blood flow during stimulation. Lotus cream addresses this problem as it contains "vasodilators", including sildenafil (Viagra) and other substances that relax blood flow to the genitalia resulting in the normal, youthful engorgement of the genitalia.
. Please review FAQ's below to see how Addyi differs from our Lotus cream.
Summary of FDA rejections and approval of Addyi:
October 2010 The FDA rejects Boehringer Ingelheim’s flibanserin for female sexual disorder, saying there is little evidence it increases libido and citing unacceptable side-effects. The company sells it to Sprout.
October 2013 Second FDA rejection.
August 2015 FDA approves flibanserin, given the brand name Addyi by Sprout, but with a black box warning of side-effects. Critics cite pressure from women's groups, including Even The Score, a group that claimed the FDA was guilty of gender inequality in approval of drugs for men but not women for sexual dysfunction. The group describes itself as “created to serve as a voice for American women who believe that it’s time to level the playing field when it comes to the treatment of women’s sexual dysfunction”. Please read FAQ's below for more information.
Frequently Asked Questions regarding Addyi and our Lotus cream
Q: Is Addyi the"female viagra"?
A: No, Addyi does not work to increase blood flow to the genitals during arousal like Viagra and Lotus cream does. Rather, Addyi works on brain chemicals to increase libido and has no direct effect on female genitalia.
Q: How does Addyi work compared to Lotus Cream?
A: Addyi reportedly increase chemicals in the brain associated with sexual satisfaction, whereas Lotus cream causes increase blood flow to the genitals during arousal and orgasm, a normal physiologic function in women that in many women diminishes with age. According to the studies for Addyi, women can expect less than ONE extra satisfying sexual experience per month. Remember, this is when the pill is taken daily and you cannot have alcohol, at all. The FDA, which approved Addyi, admits it does not know how Addyi works : "the mechanism by which the drug improves sexual desire and related distress is not known." (source: FDA website)
Q: How are they both taken?
A: Addyi is a pill that must be taken daily, whereas Lotus cream is used daily or as needed
Q: Can I drink alcohol while taking either Addyi or Lotus cream?
A: Alcohol is a contraindicated for women taking Addyi, whereas there is no interaction or negative effect at all with alcohol and Lotus.
Q: Are there side effects with Addyi?
A: There are many potential side effects with Addyi, the most serious is passing out due to low blood pressure, an effect that increases significantly if one ingests alcohol or takes in conjunction with certain medications. Lotus cream can be taken with any medication and alcohol. Other side effects of Addyi include nausea, somnolence, fatigue, dizziness, and insomnia.
Q: What is the liklihood of my condition improving with Addyi? How about with Lotus cream?
A: Clinical studies show that women who took Addyi daily experienced on average one-half to one more satisfying sexual experience per month. Dr. Carr's experience with Lotus cream shows that for women who have decreased genital response with stimulation, that most notice some degree of improvement when using Lotus cream, and for many women the improvement is significant.
Q. What age groups were studied for Addyi and for whom is it approved? How about Lotus cream?
A: Addyi was studied and approved for pre-menopausal women only. It is not recommend nor was it studied in the group of women that suffer the most common from sexual dysfunction, namely post-menopausal women.
Directly from the Addyi website: “ADDYI is not for use for the treatment of HSDD in women who have gone through menopause or in men.”
Lotus cream may be used in adult women of all ages.
Q: Do either Addyi or Lotus cream contain hormones?
A: No. There are no hormones in either Addyi or Lotus cream.
Q: Can my doctor prescribe Addyi for me?
A: ADDYI is available only through a restricted program called the "ADDYI REMS" Program, because of the increased risk of severe hypotension and syncope due to an interaction between ADDYI and alcohol. If a doctor does not complete the training course, he/she cannot prescribe the drug. In Dr. Carr's 28 years in medicine, he has never had to take a course to prescribe a medication.
Q: Why haven't I heard of either of these treatments before?
A: Lotus cream is made by a compounding pharmacy to the specifications of Dr. Carr, with substances chosen based on experience and the underlying problem in many women who have sexual dysfunction, which includes decreased blood flow and genital arousal. It is NOT FDA approved because it is a compounded substance and the FDA does to approve or disapprove compounding pharmaceuticals. The drug in Addyi, flibanserin, has been around since the 1980's but just approved by the FDA in August of 2015 after is was initially rejected by the FDA (proposed trade name Girosa, developed by the drug company Boehringer Ingelhiem). Flibanserin failed to show efficacy and was rejected both in 2010 and 2013. The approval in August 2015 was due in large part to pressure on the FDA to approved a product for sexual dysfunction in women by a campaign from women's groups claiming gender bias, including Even The Score (see below).